Review decisions
Showing 40 results of 359 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1753984288289
Product Type: Drug
Control Number: 272063
DIN(s): 02448254
Manufacturer: Dermavant Sciences GmbH
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-03-31
Decision / Authorization Date: 2025-04-03
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758909378800
Product Type: Drug
Control Number: 282375
DIN(s): 02458136
Manufacturer: Hoffman-La Roche Limited
Submission Type: Supplement to a New Drug Submission - Priority Review
Date Filed / Submission Date: 2023-12-22
Decision / Authorization Date: 2024-06-27
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759759362199
Product Type: Drug
Control Number: 280615
DIN(s): 02480824, 02480832, 02480840
Manufacturer: Ipsen Biopharmaceuticals Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-11-01
Decision / Authorization Date: 2024-09-12
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1760469114216
Product Type: Drug
Control Number: 279315
DIN(s): 02554070
Manufacturer: Duchesnay Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-20
Decision / Authorization Date: 2024-12-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1744297903847
Product Type: Drug
Control Number: 279373
DIN(s): 02554283, 02554291, 02554305
Manufacturer: Fresenius Kabi Canada Ltd
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-12-15
Decision / Authorization Date: 2024-12-30
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758806289537
Product Type: Drug
Control Number: 273611
DIN(s): 02550075
Manufacturer: Dr. Reddy’s Laboratories Ltd.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-04-03
Decision / Authorization Date: 2024-07-09
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1757361952411
Product Type: Drug
Control Number: 271972
DIN(s): 02556472
Manufacturer: Formative Pharma Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2023-01-31
Decision / Authorization Date: 2025-03-20
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1759769349421
Product Type: Drug
Control Number: 278913
DIN(s): 02551764, 02551772, 02551780, 02551799
Manufacturer: Blueprint Medicines Corporation/Medison Pharma Canada Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2023-09-07
Decision / Authorization Date: 2024-09-18
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1758805441754
Product Type: Drug
Control Number: 275599
Manufacturer: Tersera Therapeutics LLC
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-05-24
Decision / Authorization Date: 2024-05-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1742997691925
Product Type: Drug
Control Number: 274453
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2023-04-17
Decision / Authorization Date: 2025-02-06